Extragonadal Effects of hCG on Calcium Homeostasis

What Was Tested

In this phase 1 trial, researchers set out to test hCG (human chorionic gonadotropin).

Serum calcium level differed when comparing pretreatment values at baseline with serum levels 72 hours after hCG stimulation in men with gonadal insufficiency referred for this stimulation test.

Now the researchers want to investigate whether this change in calcium is due to renal loss or other mechanisms and how the classical regulators of calcium homeostasis respond to hCG in men with impaired gonadal function compared with men having normal gonadal function.

It had 1 arm (groups): human chorion gonadotropin (experimental).

The registry classes the interventions as drug.

More on the Plan

Aim To investigate whether human chorionic gonadotropin (hCG) stimulation test changes calcium-phosphate homeostasis in men with normal and impaired testicular function.

The overall purpose of the project is to investigate the importance of human chorion gonadotropin (hCG) for the calcium balance in normal men and men with impaired testicular function.

BACKGROUND AND HYPOTHESES The Department for Growth and Reproduction has helped to uncover the rising occurrence of early puberty, infertility, polycystic ovarian syndrome and testicular cancer that is worryingly high in large numbers parts of the world (1).

These conditions are all governed by the hormonal axis that contains hypothalamus, pituitary gland, and the HPG axis (2).

Who Took Part

Enrollment: 12 actual participants took part.

It was open to men only aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: A man with normal reproductive function. Or a man with known impaired gonadal function. More than 18 years of age and less than 80 years of age.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: presence of current serious diseases; or presence of disease requiring constant and lifelong treatment with chemotherapy or other toxic drugs; men treated with testosterone who do not stop their treatment while being part of the study,.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-01-06 with completion listed for 2022-10-31.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Serum calcium (time frame: 2,8,24, 72,120 hours).

It also tracked 2 secondary outcomes, for example urinary calcium and phosphate excretion and serum Phosphate.

What This Means in Plain Language

Put simply, this is a phase 1 trial of hCG (human chorionic gonadotropin) in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.